Treats erectile dysfunction. ANDA 206401, held by Ajanta Pharma Ltd. Sildenafil Citrate.
As of Nov 15, 2026, ANDA 206401 (Sildenafil Citrate), held by Ajanta Pharma Ltd, was first approved by FDA on Oct 12, 2018, with 0 approved supplements and 0 published complete response letters.
Sildenafil citrate is indicated for the treatment of erectile dysfunction.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2018 | Original application | Approved | None posted |
| Sildenafil CitrateEQ 25MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Sildenafil CitrateEQ 50MG BASE · tablet;oral | Sildenafil Citrate | Rx |
| Sildenafil CitrateEQ 100MG BASE · tablet;oral | Sildenafil Citrate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
